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Therapeutic Class Overview Intranasal Corticosteroids

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Therapeutic Class Overview Intranasal Corticosteroids Therapeutic Class Overview Intranasal Corticosteroids INTRODUCTION Intranasal corticosteroids are primarily used to treat perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR) and may be useful in the treatment of some forms of nonallergic rhinitis (Wallace et al, 2008). Symptoms associated with allergic rhinitis include nasal congestion, rhinorrhea, sneezing and/or nasal itching. These symptoms result from a complex allergen-driven mucosal inflammation caused by resident and infiltrating inflammatory cells and a number of vasoactive and proinflammatory mediators (Wallace et al, 2008). Treatment should consist of patient education, allergen avoidance activities and pharmacological therapies. Patients should be educated on how to avoid known triggers, such as aeroallergens, dust mites, molds and irritants whenever possible. In addition to environmental control measures, pharmacological therapies may be used to control symptoms. Intranasal corticosteroids down-regulate the inflammatory response by binding to the intracellular glucocorticoid receptors of inflammatory cells and causing a conformational change, thereby controlling the rate of protein synthesis and suppressing the transcription of cytokine and chemokine genes (Clinical Pharmacology®, 2017). Most intranasal corticosteroids are approved by the Food and Drug Administration (FDA) for the treatment of PAR and SAR. Mometasone (NASONEX®) carries an additional indication for the prophylaxis of SAR. NASACORT ALLERGY 24HR® (triamcinolone acetate), FLONASE® ALLERGY RELIEF (fluticasone propionate), FLONASE® SENSIMIST ALLERGY RELIEF (fluticasone furoate), and RHINOCORT® ALLERGY (budesonide) are all FDA-approved for over- the-counter use (Drugs@FDA, 2017). Nasal polyposis is an inflammatory condition of the nasal and sinus mucosa and usually presents as persistent nasal obstruction (Wallace et al, 200flu8). Two currently available intranasal corticosteroids, beclomethasone (BECONASE AQ®) and mometasone (NASONEX®) are also FDA-approved for the management of nasal polyps. Beclomethasone (BECONASE AQ) and fluticasone propionate are approved for the management of nonallergic rhinitis (eg, infectious rhinitis, hormonal rhinitis and vasomotor nonallergic rhinitis with eosinophilia syndrome). Unlike allergic rhinitis, nonallergic rhinitis is characterized by periodic or perennial symptoms that are not a result of immunoglobulin E-dependent events (Wallace et al, 2008). Beclomethasone (QNASL™) and ciclesonide (ZETONNA®) are the only two intranasal corticosteroid products formulated as a “dry” nasal aerosol; all other products within the class are formulated as aqueous suspensions. Recently, VERAMYST® (fluticasone furoate) was withdrawn from the market after over-the-counter FLONASE® SENSIMIST™ ALLERGY RELIEF (fluticasone furoate) was launched (GlaxoSmithKline press release, 2017; Snyder- Bulik, 2017). Continuous administration of intranasal corticosteroids is more efficacious than as-needed dosing, and the onset of therapeutic effect occurs between three and twelve hours (Wallace et al, 2008). As a result of both the route of administration and the relatively low systemic bioavailability of these agents, intranasal corticosteroids are generally not associated with any clinically significant systemic adverse events. Moreover, drug interactions are limited when administered at recommended doses. The most common adverse events include nasal irritation and mild epistaxis. The agents included in this review are listed in Table 1 by brand name. Since there are some branded agents that contain the same generic component, the remaining tables in the review are organized by generic name. Medispan Class: Nasal Steroids Data as of May 22, 2017 YP-U/KS-U/LMR Page 1 of 14 This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorized recipients. Table 1. Medications Included Within Class Review Generic Drug Manufacturer FDA Approval Date Availability BECONASE AQ (beclomethasone GlaxoSmithKline 07/27/1987 - dipropionate monohydrate) FLONASE ALLERGY RELIEF† (fluticasone GlaxoSmithKline 07/23/2014 propionate) FLONASE SENSIMIST ALLERGY RELIEF† GlaxoSmithKline 08/02/2016 - (fluticasone furoate) flunisolide* Various 09/24/1981 fluticasone propionate* Various 10/19/1994 NASACORT ALLERGY 24HR† (triamcinolone Sanofi 10/11/2013 acetonide) NASONEX (mometasone furoate Merck Sharp Dohme 10/01/1997 monohydrate) OMNARIS® (ciclesonide) Sunovion 11/21/2007 - QNASL (beclomethasone dipropionate) Teva Branded Pharm 03/23/2012 - RHINOCORT ALLERGY† (budesonide) McNeil Consumer 03/23/2015 Healthcare RHINOCORT AQUA (budesonide) AstraZeneca 10/01/1999 triamcinolone* Various 05/20/1996 ZETONNA (ciclesonide) Sunovion 01/20/2012 - *Brand prescription FLONASE (fluticasone propionate), NASALIDE (flunisolide), and NASACORT AQ (triamcinolone) are no longer marketed; however, generics for these products are available. †Over-the-counter product (Drugs@FDA, 2017; Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, 2017; Drug Facts and Comparisons, 2017) Data as of May 22, 2017 YP-U/KS-U/LMR Page 2 of 14 This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorized recipients. INDICATIONS Table 2. Food and Drug Administration-Approved Indications Indication (OTC) (OTC) (OTC) (OTC) furoate propionate propionate propionate propionate Flunisolide Fluticasone Fluticasone Fluticasone Fluticasone Fluticasone Ciclesonide Ciclesonide Budesonide Budesonide Budesonide Mometasone Mometasone furoate (OTC) Triamcinolone Triamcinolone Triamcinolone Triamcinolone Beclomethasone Beclomethasone Indications for Prescription Products Treatment/relief of symptoms of SAR and PAR (age (age (age ≥6)* ≥12)† ≥2) Treatment of nasal symptoms of SAR (age (age (age (age (age (age ≥4)‡ ≥6) ≥6)§ ≥6) ≥2) ≥2) Treatment of nasal symptoms of PAR (age (age (age (age (age (age ≥4)‡ ≥6) ≥12)§ ≥6) ≥2) ≥2) Treatment/relief of nasal congestion associated (age with SAR ≥2) Prophylaxis of nasal symptoms of SAR (age ≥12) Relief of symptoms of nonallergic (vasomotor) (age rhinitis ≥6)* Management of nasal symptoms of perennial (age nonallergic rhinitis ≥4) Treatment of nasal polyps (age ≥18) Prevention of recurrence of nasal polyps following (age surgical removal ≥6)* Data as of May 22, 2017 YP-U/KS-U/LMR Page 3 of 14 This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorized recipients. OTC Uses Temporary relief of symptoms of hay fever or other upper respiratory allergies: nasal congestion, (age (age runny nose, sneezing, and itchy nose ≥6) ≥2) Temporary relief of symptoms of hay fever or other upper respiratory allergies: nasal congestion, (age (age runny nose, sneezing, itchy nose, and itchy, ≥2)║ ≥4) watery eyes OTC = over-the-counter *Beconase AQ †Zetonna ‡Qnasl §Omnaris ║Itchy, watery eyes use is for patients ≥12 years of age (Prescribing information: BECONASE AQ, 2015; FLONASE ALLERGY RELIEF, 2015; FLONASE SENSIMIST, 2017; flunisolide, 2016; fluticasone propionate, 2017; NASACORT ALLERGY 24HR, 2016; NASONEX, 2013; OMNARIS, 2016; QNASL, 2016; RHINOCORT ALLERGY, 2016; RHINOCORT AQUA, 2016; triamcinolone, 2013; ZETONNA, 2014) Information on indications, mechanism of action, pharmacokinetics, dosing, and safety has been obtained from the prescribing information for the individual products, except where noted otherwise. Data as of May 22, 2017 YP-U/KS-U/LMR Page 4 of 14 This information is considered confidential and proprietary to OptumRx. It is intended for internal use only and should be disseminated only to authorized recipients. CLINICAL EFFICACY SUMMARY Daily administration of intranasal corticosteroids is associated with statistically significant improvements in allergy- related total nasal symptom score (TNSS) and health related quality of life scores. Numerous head-to-head clinical trials comparing the available intranasal corticosteroids have generally demonstrated no significant clinical differences among the available intranasal corticosteroids with regard to efficacy. Some studies have reported differences in sensory perceptions and patient preference with one agent compared to another. Patients administering the agents noted differences in odor, aftertaste, and severity of irritation, though these differences were not associated with differences in efficacy between the agents (Aasand et al, 1982; Al-Mohaimeid, 1993; Andersson et al, 1995; Bachert et al, 2002; Bachert et al, 2004; Berger et al, 2003; Day et al, 1998; Drouin et al 1996; Graft et al, 1996; Gross et al, 2002; Haye et al, 1993; Hebert et al, 1996; Khanna et al, 2005; LaForce et al, 1994; Langrick, 1984; Lumry et al, 2003; Mak et al, 2013; Mandl et al, 1997; McAllen et al, 1980; McArthur, 1994; Meltzer et al, 2005; Meltzer et al, 2008; Meltzer et al, 2010; Naclerio et al, 2003; Ratner et al, 1992; Sahay et al, 1980; Shah et al, 2003; Sipila et al, 1983; Small et al, 1997; Stern et al, 1997; Stokes et al, 2004; Svendsen et al, 1989; Van As et al, 1993; Vanzieleghem et al, 1987; Varshney et al, 2012; Welsh et al, 1987; Winder et al, 1993, Yonezaki et al, 2016). Head-to-head trials evaluating the efficacy and safety of beclomethasone, fluticasone propionate and flunisolide demonstrate that these agents are comparable to other agents
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